Transcatheter prosthetic heart valve post-dilatation remodeling devices and methods

ABSTRACT

A system and method for restoring (e.g., replacing) a defective heart valve of a patient. A delivery system is manipulated to percutaneously deliver and implant a stented prosthetic heart valve to a native heart valve. A post-dilatation balloon is percutaneously delivered to the implantation site, and a compliant segment thereof is arranged within a region of the implanted prosthesis. The balloon is inflated such that the compliant segment expands and contacts the prosthesis, expanding a remodeling region of the prosthesis to a remodeled state. With these and related techniques, remodeling of an implanted, stented prosthetic heart valve to better match the native valve shape is possible, providing many benefits such as reducing the risk of paravalvular leaks.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a Continuation of U.S. patent application Ser. No.14/031,330, filed Sep. 19, 2013, now allowed, which is a Division of andclaims priority to U.S. patent application Ser. No. 13/094,455 filedApr. 26, 2011, now U.S. Pat. No. 8,568,474, which claims priority under35 U.S.C. § 119(e)(1) to U.S. Provisional Patent Application Ser. No.61/328,068, filed Apr. 26, 2010, the entire teachings of which areincorporated herein by reference.

BACKGROUND

The present disclosure relates to systems, devices, and methods forpercutaneous implantation of a prosthetic heart valve. Moreparticularly, it relates to systems, devices, and methods forpercutaneously remodeling an implanted stented prosthetic heart valve.

Diseased or otherwise deficient heart valves can be repaired or replacedwith an implanted prosthetic heart valve. Conventionally, heart valvereplacement surgery is an open-heart procedure conducted under generalanesthesia, during which the heart is stopped and blood flow iscontrolled by a heart-lung bypass machine. Traditional open surgeryinflicts significant patient trauma and discomfort, and exposes thepatient to a number of potential risks, such as infection, stroke, renalfailure, and adverse effects associated with the use of the heart-lungbypass machine, for example.

Due to the drawbacks of open-heart surgical procedures, there has beenan increased interest in minimally invasive and percutaneous replacementof cardiac valves. With percutaneous transcatheter (or transluminal)techniques, a valve prosthesis is compacted for delivery in a catheterand then advanced, for example, through an opening in the femoral arteryand through the descending aorta to the heart, where the prosthesis isthen deployed in the annulus of the valve to be replaced (e.g., theaortic valve annulus). Although transcatheter techniques have attainedwidespread acceptance with respect to the delivery of conventionalstents to restore vessel patency, only mixed results have been realizedwith percutaneous delivery of the more complex prosthetic heart valve.

Various types and configurations of prosthetic heart valves areavailable for percutaneous valve procedures, and continue to be refined.The actual shape and configuration of any particular transcatheterprosthetic heart valve is dependent to some extent upon the native shapeand size of the valve being repaired (i.e., mitral valve, tricuspidvalve, aortic valve, or pulmonary valve). In general, prosthetic heartvalve designs attempt to replicate the functions of the valve beingreplaced and thus will include valve leaflet-like structures. With abioprostheses construction, the replacement valve may include a valvedvein segment that is mounted in some manner within an expandable stentframe to make a valved stent (or “stented prosthetic heart valve”). Formany percutaneous delivery and implantation devices, the stent frame ofthe valved stent is made of a self-expanding material and construction.With these devices, the valved stent is crimped down to a desired sizeand held in that compressed arrangement within an outer sheath, forexample. Retracting the sheath from the valved stent allows the stent toself-expand to a larger diameter, such as when the valved stent is in adesired position within a patient. In other percutaneous implantationsystems, the valved stent can be initially provided in an expanded oruncrimped condition, then crimped or compressed on a balloon portion ofa catheter until it is as close to the diameter of the catheter aspossible. Once delivered to the implantation site, the balloon isinflated to deploy the prosthesis. With either of these types ofpercutaneous stented valve delivery devices, conventional sewing of theprosthetic heart valve to the patient's native tissue is typically notnecessary.

With transcatheter delivery, it is imperative that the stentedprosthetic heart valve be accurately located relative to the nativeannulus immediately prior to full deployment from the catheter assuccessful implantation requires the prosthetic heart valve tointimately lodge and seal against the native annulus. If the prosthesisis incorrectly positioned relative to the native annulus, seriouscomplications can result such as leaks or even dislodgement from thenative valve implantation site. Further, even if optimally located,problems may arise if the implanted prosthesis does not closely “fit”the native anatomy, including paravalvular leakage, migration due tohydrodynamic forces, and damage to surrounding tissues (e.g., aorta,cardiac tissue, etc.). As a point of reference, these same concerns donot normally arise in the context of conventional vascular stentimplantation; with these procedures, the stent will perform its intendedfunction regardless of whether the expanded shape closely matches thenative anatomy.

In light of the above concerns, a clinician may employ imagingtechnology to evaluate the native heart valve anatomy prior toperforming the implantation procedure, selecting an optimally sizedprosthesis based on the evaluation. However, only the size of theselected prosthesis is affected by this evaluation, and not the overallshape. Thus, while the differently sized transcatheter prosthetic heartvalves made available to the clinician are generally shaped inaccordance with the expected native valve anatomy, it is unlikely that aselected prosthesis will actually “match” the actual native shape.Further, there are significant limitations associated with currentimaging-based sizing procedures for transcatheter prosthetic heartvalves. For example, measurements are currently only taken in one or twodimensional views and therefore may not account for annular ellipticity;identifying the true leaflet basal hinge point can be difficult withcalcification, imaging errors, and the non-orthogonal geometry of atricuspid valve; unknown annular compliance makes cross-sectionalgeometry of an implanted stent frame difficult to predict, which canlead to unacceptable stent aspect ratios and replacement valveperformance; and variable calcification profiles may interactunpredictably with the stent frame. Unfortunately, conventionaltranscatheter prosthetic heart valve implantation devices do not readilypermit in situ remodeling or shaping of a deployed heart valveprosthesis.

In light of the above, a need exists for transcatheter prosthetic heartvalve delivery systems and methods that facilitate modeling of animplanted prosthesis to the native valve anatomy.

SUMMARY

Some aspects in accordance with principles of the present disclosurerelate to a method of restoring (e.g., replacing) a defective heartvalve of a patient. The method includes manipulating a delivery deviceto percutaneously deliver a stented prosthetic heart valve in acompressed arrangement to an implantation site of the defective heartvalve. The stented prosthetic heart valve includes a stent frame towhich a valve structure is attached, with the stent frame beingconfigured to radially self-expand from the compressed arrangement. Thedelivery device is operated to release the stented prosthetic heartvalve, including permitting the stent frame to self-expand from thecompressed arrangement toward a deployed arrangement in which theprosthesis is implanted within the defective heart valve in an initialstate. A post-dilatation balloon is percutaneously delivered, in adeflated state, to the implantation site. A compliant segment of theballoon is arranged within a region of the implanted stented prostheticheart valve for which remodeling is desired. The balloon is theninflated such that the compliant segment expands and contacts theimplanted stented prosthetic heart valve in the remodeling region. Theremodeling region is expanded from the initial state via continuedinflation of the compliant segment to alter a shape of the implantedprosthetic heart valve to a remodeled state. In some embodiments, themethod includes directing the delivery device through a catheter todeliver the compressed prosthesis to the implantation site, followed byremoval of the delivery device and subsequent insertion of the balloonthrough the catheter. In other embodiments, the implanted prostheticheart valve defines an inflow side and an outflow side, with thecompliant segment contacting the stent frame at a location between theinflow and outflow sides. In related embodiments, the balloon furtherincludes first and second segments at immediately opposite sides of thecompliant segment, respectively, with the first and second segmentsexpanding to a predetermined maximum outer diameter while the compliantsegment increases in maximum outer diameter with continued inflation ofthe balloon. With these and related techniques, remodeling of animplanted, stented prosthetic heart valve to better match the nativeshape is possible, providing many benefits such as reducing the risk ofparavalvular leaks, optimal valve hydrodynamic performance, anddurability.

Other aspects in accordance with principles of the present disclosurerelate to a system for percutaneously restoring (e.g., replacing) anative heart valve of a patient. The system includes a stentedprosthetic heart valve, a delivery device, and a post-dilatation balloonassembly. The stented prosthetic heart valve has a stent frame to whicha valve structure is attached. The stent frame is configured to radiallyself-expand from a compressed arrangement. The delivery device includesa delivery sheath sized for percutaneously accessing a native heartvalve. The delivery device provides a delivery state in which thedelivery sheath compressively maintains the stented prosthetic heartvalve in the compressed arrangement, as well as a deployment state inwhich the delivery sheath is withdrawn from the stented prosthetic heartvalve to permit the prosthesis to self-expand from the compressedarrangement to a normal, expanded arrangement. The post-dilatationballoon assembly includes a catheter and a balloon fluidly attached tothe catheter. The balloon is sized for percutaneously accessing thestented prosthetic heart valve once implanted to the native heart valve.In this regard, the balloon includes a compliant segment having alongitudinal length that is less than a longitudinal length of theprosthetic heart valve. Further, a maximum outer diameter of thecompliant segment continuously expands with continuous inflation of theballoon. In some embodiments, the compliant segment has, in an inflatedstate of the balloon, an obround shape in longitudinal cross-section. Inother embodiments, the balloon further defines first and second segmentsat immediately opposite sides of the compliant segment, respectively,with the first and second segments being less compliant than thecompliant segment. In related embodiments, a wall thickness of theballoon along the compliant segment is less than a wall thickness of theballoon along the first and second segments.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a side view of a stented prosthetic heart valve useful withsystems, devices, and methods of the present disclosure and in a normal,expanded arrangement;

FIG. 1B is a side view of the prosthesis of FIG. 1A and in a compressedarrangement;

FIG. 2 is a perspective view of a system for restoring (e.g., replacing)a defective heart valve of a patient in accordance with principles ofthe present disclosure and with which the prosthesis of FIG. 1A isuseful;

FIG. 3A is a simplified side view of a portion of a post-dilatationassembly component of the system of FIG. 2, including a balloon in afirst profile of an inflated state;

FIG. 3B is a simplified side view of the post-dilatation assembly ofFIG. 3A, including the balloon in a second profile of the inflatedstate;

FIG. 4 is a simplified side view illustrating a comparison of theballoon of FIGS. 3A and 3B with the prosthetic heart valve of FIG. 1A;

FIG. 5 is a simplified side view of a portion of another post-dilatationassembly in accordance with principles of the present disclosure andillustrating a comparison with the prosthetic heart valve of FIG. 1A;

FIG. 6 is a simplified side view of another balloon useful with thepost-dilatation assembly of FIG. 2;

FIGS. 7A and 7B illustrate a comparison of the balloon of FIG. 6 withthe prosthetic heart valve of FIG. 1A;

FIG. 8 is a perspective exploded view of a delivery device portion ofthe system of FIG. 2;

FIG. 9A is a simplified side view of the delivery device of FIG. 8loaded with the prosthetic heart valve of FIG. 1B;

FIG. 9B is a simplified cross-sectional view of the loaded deliverydevice of FIG. 9A;

FIG. 10 is a flow diagram of a method for repairing a defective heartvalve in accordance with principles of the present disclosure;

FIGS. 11A and 11B are simplified anatomical views of a delivery devicepercutaneously implanting a stented heart valve; and

FIGS. 12A-12C illustrate various steps of the method of FIG. 10.

DETAILED DESCRIPTION

As referred to herein, stented transcatheter prosthetic heart valvesuseful with and/or as part of the various systems, devices, and methodsof the present disclosure may assume a wide variety of differentconfigurations, such as a bioprosthetic heart valve having tissueleaflets or a synthetic heart valve having a polymeric, metallic, ortissue-engineered leaflets, and can be specifically configured forreplacing any heart valve. Thus, the stented prosthetic heart valveuseful with the systems, devices, and methods of the present disclosurecan be generally used for replacement of a native aortic, mitral,pulmonic, or tricuspid valves, for use as a venous valve, or to replacea failed bioprosthesis, such as in the area of an aortic valve or mitralvalve, for example.

In general terms, the stented prosthetic heart valves of the presentdisclosure include a stent or stent frame maintaining a valve structure(tissue or synthetic), with the stent having a normal, expandedarrangement and collapsible to a compressed arrangement for loadingwithin a delivery system. The stent is normally constructed toself-deploy or self-expand when released from the delivery system. Forexample, the stented prosthetic heart valve useful with the presentdisclosure can be a prosthetic valve sold under the trade nameCoreValve® available from Medtronic CoreValve, LLC. Other non-limitingexamples of transcatheter heart valve prostheses useful with systems,devices, and methods of the present disclosure are described in U.S.Publication Nos. 2006/0265056; 2007/0239266; and 2007/0239269, theteachings of each which are incorporated herein by reference. The stentsor stent frames are support structures that comprise a number of strutsor wire portions arranged relative to each other to provide a desiredcompressibility and strength to the prosthetic heart valve. In generalterms, the stents or stent frames of the present disclosure aregenerally tubular support structures having an internal area in whichvalve structure leaflets will be secured. The leaflets can be formedfrom a variety of materials, such as autologous tissue, xenographmaterial, or synthetics as are known in the art. The leaflets may beprovided as a homogenous, biological valve structure, such as porcine,bovine, or equine valves. Alternatively, the leaflets can be providedindependent of one another (e.g., bovine or equine pericardial leaflets)and subsequently assembled to the support structure of the stent frame.In another alternative, the stent frame and leaflets can be fabricatedat the same time, such as may be accomplished using high-strengthnano-manufactured NiTi films produced at Advance BioProsthetic Surfaces(ABPS), for example. The stent frame support structures are generallyconfigured to accommodate at least two (typically three) leaflets;however, replacement prosthetic heart valves of the types describedherein can incorporate more or less than three leaflets.

Some embodiments of the stent frames can be a series of wires or wiresegments arranged such that they are capable of self-transitioning froma compressed or collapsed arrangement to a normal, radially expandedarrangement. In some constructions, a number of individual wirescomprising the stent frame support structure can be formed of a metal orother material. These wires are arranged in such a way that the stentframe support structure allows for folding or compressing or crimping tothe compressed arrangement in which the internal diameter is smallerthan the internal diameter when in the normal, expanded arrangement. Inthe compressed arrangement, such a stent frame support structure withattached valve leaflets can be mounted onto a delivery system. The stentframe support structures are configured so that they can be changed totheir normal, expanded arrangement when desired, such as by the relativemovement of one or more outer sheaths relative to a length of the stentframe.

The wires of these stent frame support structures in embodiments of thepresent disclosure can be formed from a shape memory and/or superelasticmaterial such as a nickel titanium alloy (e.g., Nitinol™). With thismaterial, the support structure is self-expandable from the compressedarrangement to the normal, expanded arrangement, such as by theapplication of heat, energy, and the like, or by the removal of externalforces (e.g., radially compressive forces). This stent frame supportstructure can also be compressed and re-expanded multiple times withoutdamaging the structure of the stent frame. In addition, the stent framesupport structure of such an embodiment may be laser-cut from a singlepiece of material or may be assembled from a number of differentcomponents. For these types of stent frame structures, one example of adelivery device that can be used includes a catheter with a retractablesheath that covers the stent frame until it is to be deployed, at whichpoint the sheath can be retracted to allow the stent frame toself-expand. Further details of such embodiments are discussed below.

With the above understanding in mind, one non-limiting example of astented prosthetic heart valve 20 useful with systems, devices, andmethods of the present disclosure is illustrated in FIGS. 1A and 1B. Asa point of reference, the prosthetic heart valve 20 is shown in a normalor expanded arrangement in the view of FIG. 1A; FIG. 1B illustrates theprosthetic heart valve 20 in a compressed arrangement (e.g., whencompressively retained within an outer catheter or sheath). Theprosthetic heart valve 20 includes a stent or stent frame 22 and a valvestructure 24. The stent frame 22 can assume any of the forms describedabove, and is generally constructed so as to be self-expandable from thecompressed arrangement (FIG. 1B) to the normal, expanded arrangement(FIG. 1A). In other embodiments, the stent frame 22 is expandable to theexpanded arrangement by a separate device (e.g., a balloon internallylocated within the stent frame 22). The valve structure 24 is assembledto the stent frame 22 and provides two or more (typically three)leaflets 26. The valve structure 24 can assume any of the formsdescribed above, and can be assembled to the stent frame 22 in variousmanners, such as by sewing the valve structure 24 to one or more of thewire segments 28 defined by the stent frame 22.

With the but one acceptable construction of FIGS. 1A and 1B, theprosthetic heart valve 20 is configured for restoring (e.g., replacingor repairing) an aortic valve. Alternatively, other shapes are alsoenvisioned to adapt to the specific anatomy of the valve to be restored(e.g., stented prosthetic heart valves in accordance with the presentdisclosure can be shaped and/or sized for replacing a native mitral,pulmonic, or tricuspid valve). Regardless, the stent frame 22 defines anaxial length L_(P) of the prosthetic heart valve 20 as a longitudinaldistance between opposing terminal ends 30, 32. With the oneconstruction of FIGS. 1A and 1B, the valve structure 24 extends lessthan the entire length L_(P) of the stent frame 22, but in otherembodiments can extend along an entirety, or a near entirety, of thelength L_(P) of the stent frame 22. Regardless, an arrangement ororientation of the leaflets 26 establishes an inflow region 34 of theprosthetic heart valve 20, and an outflow region 36. As a point ofreference, “inflow” and “outflow” terminology is in reference to anarrangement of the prosthetic heart valve 20 upon final implantationrelative to the native aortic valve (or other valve) being replaced andthe corresponding direction of blood flow therethrough. With theseconventions, the first end 30 can serve as the inflow end of theprosthetic heart valve 20, and the second end 32 as the outflow end.Further, with the but one acceptable construction of FIG. 1A, aconstriction region 38 can be formed at a transition from the inflowregion 34 to the outflow region 36. A wide variety of constructions arealso acceptable and within the scope of the present disclosure. Forexample, the stent frame 22 can have a more cylindrical shape in thenormal, expanded arrangement.

With the above understanding of the stented prosthetic heart valve 20 inmind, one embodiment of a system 40 in accordance with the presentdisclosure and useful in restoring (e.g., replacing) a defective heartvalve is shown in FIG. 2. In addition to the prosthetic heart valve 20(hidden in the view of FIG. 2), the system 40 includes a delivery device42 and a post-dilatation assembly 44. Details on the various componentsare provided below. In general terms, however, the delivery device 42 istransitionable from a loaded state (shown in FIG. 2) in which thestented prosthetic heart valve 20 is contained within an outer deliverysheath 46 of the delivery device 42, to a deployed state in which thedelivery sheath 46 is retracted from the prosthetic heart valve 20,thereby permitting the prosthetic heart valve 20 to self-expand (oralternatively be caused to expand by a separate mechanism) and releasefrom the delivery device 42. Once released, the prosthesis 20 isimplanted to the anatomy of the native valve being restored.Subsequently, a balloon 50 of the post-dilatation assembly 44 ispercutaneously deployed and operated to remodel a region of theimplanted prosthetic heart valve 20 as desired by the clinician. Moregenerally, principles of the present disclosure are related toconstruction and/or implementation of the post-dilatation assembly 44 inremodeling an implanted prosthetic heart valve. The stented prostheticheart valve 20 and the delivery device 42 can thus assume a plethora ofdifferent configurations directly or indirectly implicated by thedescriptions provided herein.

The post-dilatation assembly 44 includes the balloon 50 and a catheter52. The catheter 52 is coupled to the balloon 50 (or integrally formsthe balloon 50), and fluidly connects the balloon 50 with an inflationsource (not shown). Thus, the catheter 52 can assume any conventionalform appropriate for percutaneously delivering the balloon 50 through apatient's vasculature (e.g., through the femoral artery and to thenative valve to be repaired, such as across the aortic arch), such as aPEBAX® or other biocompatible plastic material catheter. The catheter 52can optionally incorporate other features as desired (e.g., braidedreinforced wall, a spring coil, guide wire lumen, multiple ports, etc.).Regardless, the catheter 52 extends between proximal and distal portions54, 56 and establishes an inflation lumen (hidden in FIG. 2). Theproximal portion 54 is connectable (e.g., via a manifold) to theinflation source, with the inflation lumen establishing a fluidconnection between the inflation source and the balloon 50.

The balloon 50 is mounted to the distal portion 56 of the catheter 52,and is inflatable from the deflated state generally reflected in FIG. 2to an inflated state configured to interface with an implanted stentedprosthetic heart valve in a desired manner. For example, FIG. 3Aillustrates the balloon 50 in a first profile of an inflated state, withthe balloon 50 defining an intermediate segment 60, and opposing firstand second end segments 62, 64. A compliance of the intermediate segment60 is greater than that of the first end segment 62 and the second endsegment 64. Stated otherwise, with continued inflation (e.g., increasedinternal pressure) of the balloon 50 from the first profile of theinflated state of FIG. 3A, the intermediate segment 60 will continue toexpand in outer diameter at an elevated rate as compared to expansion ofthe end segment 62, 64, for example to a second profile of the inflatedstate shown in FIG. 3B. Thus, the intermediate segment 60 can bereferred to as the compliant segment of the balloon 50. In someembodiments, the first and second end segments 62, 64 are essentiallynon-compliant, and will not radially expand beyond the predeterminedshapes implicated by FIGS. 3A and 3B at expected inflation pressures(e.g., on the order of 0.5-8.0 ATM). That is to say, a shape and outerdiameter of the end segments 62, 64 are essentially fixed uponinflation, regardless of inflation pressure, with the balloon 50assuming the three-lobed shape as shown (with externally unconstrainedexpansion). While the intermediate segment 60 is radially expandable orcompliant at least at the expected inflation pressures, the balloon 50as a whole is substantially non-compliant in longitudinal length. Alongitudinal working length L_(B) of the balloon 50 remainssubstantially unchanged (e.g., no more than 5% change in longitudinallength) with continuous inflation of the balloon 50 (e.g., transitioningbetween the first and second profiles).

The intermediate compliant segment 60 is sized and shaped to interfacewith a selected region of the expanded, implanted prosthetic heart valve20 (FIG. 1A), with this region being less than the longitudinal lengthL_(P) (FIG. 1A) of the prosthesis 20. For example, in the inflated stateof FIGS. 3A and 3B, the compliant segment 60 has a longitudinal lengthL_(CS) that is less than the prosthesis length L. Thus, while thelongitudinal working length L_(B) of the balloon 50 may approximate (orexceed) the prosthesis length L_(P), the compliant segment length L_(CS)dictates that the compliant segment 60 will interface with or contactonly a relatively small region or area of the implanted prosthetic heartvalve 20 upon inflation and as described below. For example, thecompliant segment 60 can be sized to interface with the constrictionregion 38 (FIG. 1A). The compliant segment 60 has, upon inflation, agenerally obround shape in longitudinal cross-section, although othershapes (such as cylindrical) are also envisioned.

The first end segment 62 can have a predetermined shape in the inflatedstate selected to generally match an expected shape of a correspondingregion of the deployed prosthetic heart valve 20 (FIG. 1A). For example,the inflated first end segment 62 can have the somewhat rounded shape asshown that otherwise mimics the expected shape of the outflow region 36(FIG. 1A) of the deployed prosthetic heart valve 20. In this regard, ashape of the first end segment 62 in the inflated state can have ordefine a central section 70 and opposing, proximal and distal necksections 72, 74. The central section 70 defines a maximum inflated outerdiameter of the first end segment 62 (e.g., where the first end segment62 is essentially non-compliant at expected inflation pressures, themaximum inflated outer diameter of the first end segment 62 is fixed)that can correspond with the expected maximum inner diameter of theoutflow region 36. The proximal neck section 72 tapers in outer diameter(e.g., a fixed taper) from the central section 70 to a point ofattachment with the catheter 52. The distal neck section 74 tapers inouter diameter (e.g., a fixed taper) from the central section 70 to thecompliant segment 60. Other shapes (e.g., cylindrical) are alsoenvisioned.

The second end segment 64 can also have a predetermined shape in theinflated state selected to generally correspond with an expected shapeof a different region of the deployed prosthetic heart valve 20 (FIG.1A). For example, the inflated second end segment 64 can have thesomewhat elliptical shape as shown that otherwise mimics the expectedshape of the inflow region 34 (FIG. 1A) of the deployed prosthesis 20.In this regard, a shape of the second end segment 64 in the inflatedstate can have or define a central section 80, and opposing, proximaland distal neck sections 82, 84. The central section 80 defines amaximum inflated outer diameter of the second end segment 64 (e.g.,where the second end segment 64 is essentially non-compliant at expectedinflation pressures, the maximum inflated outer diameter of the secondend segment 64 is fixed) that can correspond with the expected maximuminner diameter of the inflow region 34. The proximal and distal necksections 82, 84 can taper in outer diameter as shown, with this taperbeing fixed in some embodiments. Other shapes (e.g., cylindrical) arealso envisioned.

The balloon 50 can be constructed in a variety of fashions. For example,in some embodiments, the balloon 50 is formed by blow-molding auniaxially oriented polymer tube with a variable wall thickness. Thevariable wall thickness tube can be formed by post-necking an extrudedtube. With this technique, the variable compliance attributes associatedwith the segments 60-64 as described above are achieved via the variablewall thickness. For example, a wall thickness of the balloon 50 alongthe compliant segment 60 is less than that of the end segments 62, 64,thereby rendering the compliant segment 60 more compliant than the endsegments 62, 64. Other materials and/or manufacturing techniques arealso envisioned. For example, an expansion limiting band or otherinflation limiting structure can be applied (internally or externally)to one or both of the end segments 62, 64; the balloon segments 60-64can be formed with different levels of cross-linking; differentmaterial(s) can be employed for the segments 60-64; etc. Regardless, thecompliant segment 60 facilitates remodeling of a region of the implantedprosthetic heart valve 20 (FIG. 1A), whereas the less-compliant endsegments 62, 64 serve to better locate, prevent migration, and supportthe compliant segment 60 during inflation.

The balloon 50 can be connected to the catheter 52 in various manners.For example, the balloon 50 can be an integrally formed component orextension of the catheter 52 tubing in accordance with the blow-moldingtechniques described above. Alternatively, the balloon 50 and thecatheter 52 can be separately formed and subsequently assembled (e.g.,adhesive bond; heat shrink; etc.). In some embodiments, a distal end 86of the catheter 52 is provided distal the balloon 50 (i.e., the distalend 86 extends from the second end segment 64 of the balloon 50 in adirection opposite the compliant segment 60), for example by mountingthe distal end 86 to the balloon 50 and/or via the integral moldingtechniques above. Regardless, one or more visual markers 88 (e.g.,radiopaque band) can be applied along the catheter 52 at a location orlocations immediately adjacent the balloon 50 to assist in properlylocating the balloon 50 during use.

As mentioned above, a size and shape of the balloon 50 is selected basedupon the general size and shape of the prosthetic heart valve 20 (FIG.1A) for which the balloon 50 will be used to remodel. By way of example,FIG. 4 provides a comparison of the balloon 50 with the prosthetic heartvalve 20 in the normal, expanded arrangement. In the inflated state, thecompliant segment length L_(CS) is less than the prosthesis length L_(P)(e.g., the compliant segment length L_(CS) is no more than 75% of theprosthesis length L_(P); in other embodiments, no more than 50%; and inyet other embodiments, no more than 40%). In one embodiment, thecompliant segment length L_(CS) is selected to approximate alongitudinal length of the constriction region 38. The first end segment62 is generally sized in accordance with the outflow region 36, and thesecond end segment 64 is generally sized in accordance with the inflowregion 34. When the balloon 50 is thus disposed within the implantedprosthetic heart valve 20 and inflated, the first end segment 62 maygenerally internally contact the stent frame 22 along the outflow region36, and the second end segment 64 may generally internally contact thestent frame 22 along the inflow region 34. With the end segments 62, 64so-located relative to the prosthetic heart valve 20, the compliantsegment 60 contacts the stent frame 22 along the constriction region 38.With continued inflation of the balloon 50 from the first profile ofFIG. 3A to the second profile of FIG. 3B, a radial expansive forceapplied to the constriction region 38 by the compliant segment 60continuously increases. In contrast, the generally non-compliant natureof the first and second end segments 62, 64 is such that intransitioning of the balloon 50 from the first profile to the secondprofile, the contacted outflow and outflow regions 34, 36 do not furtherdeflect with an increase in an inflation pressure or level of theballoon 50. Instead, the implanted prosthetic heart valve 20 iseffectively “remodeled” primarily along the region (e.g., theconstriction region 38) acted upon by the compliant segment 60.

The post-dilatation assembly 44 can incorporate additional features thatpromote positioning or anchoring of the compliant segment 60 relative tothe region of the prosthesis 20 for which remodeling is desired (e.g.,the constriction region 38). For example, FIG. 5 illustrates, insimplified form, a portion of an alternative post-dilatation assembly44′ that includes the balloon 50 and the catheter 52 as described above,as well as one or more prosthesis engagement features 90. The engagementfeatures 90 are provided along an exterior surface 92 of the balloon 50(e.g., an entire circumference of the exterior surface 92) at one orboth of the first segment 62 and/or the second segment 64. Theengagement features 90 can take various forms configured to frictionallyinterface with the stent frame 22, for example one or more of ridges,protrusions, surface roughness, high friction materials, etc. Theengagement features 90 can be integrally formed by or into the balloon50, or can be a structure apart from the balloon 50. Regardless, theengagement features 90 readily contract and expand withdeflation/inflation of the balloon 50, and interact with the stent frame22 to help anchor or position the compliant segment 60 relative to thedesired remodeling region.

While the balloon 50 has been shown and described assuming the tri-lobedshape in the inflated state, other constructions are also acceptable.For example, one or both of the first and second end segments 62, 64 canbe configured to have shapes differing from those illustrated. In yetother embodiments, the balloon 50 can include additional lobes in theinflated state. Conversely, one or both of the first and second endsegments 62, 64 can be omitted.

For example, FIG. 6 illustrates, in simplified form, another balloon 100in accordance with the present disclosure and useful with thepost-dilatation assembly 44 (FIG. 2). The balloon 100 is assembled tothe catheter 52 and consists of a compliant segment 102 akin to thecompliant segment 60 (FIG. 3A) described above. The compliant segment102 is formed to have a longitudinal length L_(CS) (in the inflatedstate) that is less than the corresponding prosthesis length L_(P) (FIG.1A), and thus is configured to effectuate remodeling of only a desiredregion of an implanted prosthetic heart valve. In the inflated state ofFIG. 6, the compliant segment 102 is disc-shaped (e.g., obround inlongitudinal cross-section), and can be formed by expanding an extrudedtube in the radial and axial directions, using applied temperature andpressure. With these and other techniques, the balloon 100 is integrallyformed with the catheter 52, but alternatively can be separatelymanufactured and assembled thereto. The balloon 100 can be formed fromvarious polymeric materials such as silicone, polyurethane, or otherbiocompatible thermoplastic elastomers such as C-Flex® available fromConsolidated Polymer Technologies, Inc., of Clearwater, Fla. Though notshown, a visual marker(s) can be applied to the catheter 52 immediatelyadjacent the balloon 100.

As compared to the balloon 50 (FIG. 3A), the balloon 100 does notinclude the first and second end segments 62, 64 (FIG. 3A). As shown inFIG. 7A, a length L_(CS) of the compliant segment 102 is less than theprosthesis length L_(P) and is selected to correspond generally with alength of a prosthesis region for which remodeling is desired, forexample the constriction region 38. When the balloon 100 is disposedwithin the implanted prosthetic heart valve 20, the compliant segment102 can be positioned such that when expanded, the compliant segment 102is spaced from, and thus does not contact, the prosthetic heart valveleaflets 26 (referenced generally in FIG. 7A). With continued inflation,the compliant segment 102 will radially expand, but maintain asubstantially fixed length. As a result, the constriction region 38 ofthe prosthetic heart valve 20 can be remodeled as shown in FIG. 7B withminimal or no expansive forces being placed upon the leaflets 26 by theballoon 100. Thus, the opportunity for possible damage to the leaflets26 during remodeling is reduced.

Returning to FIG. 2, the delivery device 42 can assume various forms andgenerally includes the outer delivery sheath 46, an inner shaft assembly110 (referenced generally), a handle 112, and an optional outerstability tube 114.

Representative configurations of the components 46, 110, 112, and 114 inaccordance with some embodiments of delivery devices encompassed by thepresent disclosure are shown in greater detail in FIG. 8. In thisregard, various features illustrated in FIG. 8 can be modified orreplaced with differing structures and/or mechanisms. Thus, the presentdisclosure is in no way limited to the outer delivery sheath 46, theinner shaft assembly 110, the handle 112, or the stability tube 114 asshown and described below. In more general terms, then, delivery devicesin accordance with principles of the present disclosure provide featurescapable of compressively retaining a self-expanding, stented prostheticheart valve (e.g., the outer delivery sheath 46), along with one or moremechanisms capable of effectuating release or deployment of the heartvalve prosthesis from the delivery device.

The outer delivery sheath 46 can include a capsule 120 and a shaft 122,and defines a lumen 124 (referenced generally) extending from a distalend 126 to a proximal end 128. The capsule 120 is attached to, andextends distally from, the shaft 122, and in some embodiments has a morestiffened construction (as compared to a stiffness of the shaft 122)that exhibits sufficient radial or circumferential rigidity to overtlyresist the expected expansive forces of the stented prosthetic heartvalve 20 (FIG. 1A) when compressed within the capsule 120. For example,the shaft 122 can be a polymer tube embedded with a metal braiding,whereas the capsule 120 includes a laser-cut metal tube that isoptionally embedded within a polymer covering. Alternatively, thecapsule 120 and the shaft 122 can have a more uniform construction(e.g., a continuous polymer tube). Regardless, the capsule 120 isconstructed to compressively retain the stented prosthetic heart valve20 at a predetermined diameter when loaded within the capsule 120, andthe shaft 122 serves to connect the capsule 120 with the handle 112. Theshaft 122 (as well as the capsule 120) is constructed to be sufficientlyflexible for passage through a patient's vasculature, yet exhibitssufficient longitudinal rigidity to effectuate desired axial movement ofthe capsule 120. In other words, proximal retraction of the shaft 122 isdirectly transferred to the capsule 120 and causes a correspondingproximal retraction of the capsule 120. In other embodiments, the shaft122 is further configured to transmit a rotational force or movementonto the capsule 120.

The inner shaft assembly 110 can have various constructions appropriatefor supporting a stented prosthetic heart valve within the capsule 120.For example, the inner shaft assembly 110 can include a retention member140, an intermediate tube 142, and a proximal tube 144. In generalterms, the retention member 140 can be akin to a plunger, andincorporates features for retaining the stented prosthetic heart valve20 (FIG. 1A) within the capsule 120 as described below. The intermediatetube 142 connects the retention member 140 to the proximal tube 144,with the proximal tube 144, in turn, coupling the inner shaft assembly110 with the handle 112. The components 140-144 can combine to define acontinuous lumen 146 (referenced generally) sized to slidably receive anauxiliary component such as a guide wire (not shown).

The retention member 140 can include a tip 150, a support tube 152, anda hub 154. The tip 150 forms or defines a nose cone having a distallytapering outer surface adapted to promote atraumatic contact with bodilytissue. The tip 150 can be fixed or slidable relative to the supporttube 152. The support tube 152 extends proximally from the tip 150 andis configured to internally support a compressed, stented prostheticheart valve generally disposed thereover, and has a length and outerdiameter corresponding with dimensional attributes of the prostheticheart valve. The hub 154 is attached to the support tube 152 oppositethe tip 150 (e.g., adhesive bond) and provides a coupling structure 156(referenced generally) configured to selectively capture a correspondingfeature of the prosthetic heart valve. The coupling structure 156 canassume various forms, and is generally located along an intermediateportion of the inner shaft assembly 110. In some embodiments, thecoupling structure 156 includes one or more fingers sized to be slidablyreceived within corresponding apertures formed by the prosthetic heartvalve stent frame 22 (FIG. 1A). For example, the stent frame 22 can formwire loops at a proximal end thereof that are releasably received overrespective ones of the fingers when compressed within the capsule 120.

The intermediate tube 142 is formed of a flexible material (e.g., PEEK),and is sized to be slidably received within the delivery sheath 46, andin particular the shaft 122. The proximal tube 144 can include a leadingportion 160 and a trailing portion 162. The leading portion 160 servesas a transition between intermediate and proximal tubes 142, 144, andthus can be a flexible tubing (e.g., PEEK) having a diameter slightlyless than that of the intermediate tube 142. The trailing portion 162has a more rigid construction, configured for robust assembly with thehandle 112. For example, the trailing portion 162 can be a metalhypotube, although other constructions are also acceptable. In yet otherembodiments, the intermediate and proximal tubes 142, 144 are integrallyformed as a single, homogeneous tube or solid shaft.

The handle 112 generally includes a housing 170 and an actuatormechanism 172 (referenced generally). The housing 170 maintains theactuator mechanism 172, with the actuator mechanism 172 configured tofacilitate sliding movement of the delivery sheath 46 relative to theinner shaft assembly 110, as well as relative to the optional stabilitytube 114 (where provided). The housing 170 can have any shape or sizeappropriate for convenient handling by a user. In one simplifiedconstruction, the actuator mechanism 172 includes a user interface oractuator 174 slidably retained by the housing 170 and coupled to asheath connector body 176. The proximal end 128 of the delivery sheath46 is coupled to the sheath connector body 176 (e.g., via an optionalmounting boss 178 in some embodiments). The inner shaft assembly 110,and in particular the proximal tube 144, is slidably received within apassage 180 of the sheath connector body 176, and is rigidly coupled tothe housing 170. Sliding of the actuator 174 relative to the housing 170thus causes the delivery sheath 46 to move or slide relative to theinner shaft assembly 110, for example to effectuate deployment of aprosthesis from the inner shaft assembly 110. A cap 182 can be providedfor attaching the optional outer stability tube 114 to the housing 170(such that the delivery sheath 46 is slidable relative to the stabilitytube 114 with movement of the actuator 174), and can be configured toaccommodate one or more optional port assemblies 184. In otherembodiments, the stability tube 114 can be movably coupled to thehousing 170 in a manner permitting selective sliding of the stabilitytube 114 relative to the delivery sheath 46 (and vice versa). In yetother embodiments, the stability tube 114 can be eliminated, such thatthe cap 182 is omitted as well. Similarly, the actuator mechanism 172can assume a variety of other forms differing from those implicated bythe illustration of FIG. 8.

Where provided, the stability tube 114 serves as a stability shaft forthe delivery device 42, and defines a distal end 190, a proximal end192, and a passageway 194 (referenced generally) extending between, andfluidly open at, the ends 190, 192. The passageway 194 is sized tocoaxially receive the delivery sheath 46, and in particular the shaft122, in a manner permitting sliding of the shaft 122 relative to thestability tube 114. Stated otherwise, an inner diameter of the stabilitytube 114 is slightly greater than an outer diameter of the shaft 122.The stability tube 114 has a length selected to extend over asignificant portion (e.g., at least a majority, and in otherembodiments, at least 80%) of a length of the shaft 122 in distalextension from the handle 112. Further, the stability tube 114 exhibitssufficient radial flexibility to accommodate passage through a patient'svasculature (e.g., the femoral artery, aortic arch, etc.). In yet otherembodiments, the stability tube 114 is omitted.

The system 40 (FIG. 2) can be utilized to restore (e.g., replace) adefective heart valve of a patient. Initially, the delivery device 42 isloaded with the stented prosthetic heart valve 20 as illustrated, insimplified form, in FIGS. 9A and 9B. For ease of illustration, the valvestructure 24 (FIGS. 1A and 1B) is omitted, and only the stent frame 22is shown. The prosthetic heart valve 20 is disposed over the inner shaftassembly 110, with the proximal region (e.g., outflow region) 36 beingcrimped into engagement with the coupling structure 156. The capsule 120is slidably disposed over the prosthetic heart valve 20, compressivelyretaining the prosthesis 20 about the inner shaft assembly 110. In theloaded state of FIGS. 9A and 9B, then, the prosthetic heart valve 20 iscompressed retained in the compressive arrangement by the deliverydevice 42.

With additional reference to the flow diagram of FIG. 10, one method 200for restoring (e.g., replacing) a defective heart valve begins at 202 inwhich a clinician receives the prosthetic heart valve 20/delivery device42 in the loaded state. The delivery device 42 is then, at 204,manipulated to percutaneously deliver the prosthetic heart valve 20 (inthe compressed arrangement) to a defective heart valve implantationsite. For example, the delivery device 42 is manipulated to advance theprosthetic heart valve 20 toward the implantation site in a retrogrademanner through a cut-down to the femoral artery, into the patient'sdescending aorta, over the aortic arch, through the ascending aorta, andapproximating mid-way across the defective aortic valve for an aorticvalve replacement procedure. This positioning is generally reflected inFIG. 11A. The prosthetic heart valve 20 is then deployed from thedelivery device 42 at 206. As a point of reference, prior to fulldeployment of the prosthetic heart valve 20, a partial deployment andevaluation procedure can be performed in which the prosthetic heartvalve 20 is partially deployed from the delivery device 42 and aposition of the so-deployed region relative to the implantation siteevaluated. Regardless, and as generally reflected in FIG. 11B,deployment of the prosthetic heart valve 20 generally entails retractionof the capsule 120 from the prosthetic heart valve 20 as describedabove. Once released from the delivery device 42, the prosthetic heartvalve 20 self-expands from the compressed arrangement toward a naturalarrangement, thereby self-implanting to the implantation site.

One representation of the implanted prosthetic heart valve 20 (prior toremodeling) relative to a representative native aortic heart valveanatomy 300 is shown in FIG. 12A. In the initial implanted state, thestent frame 22 has self-expanded, with the outflow region 36 expandingtoward, and aligning the prosthesis 20 within, an ascending aorta 302.The inflow region 34 has expanded within the annulus 304 of the valveanatomy 300. The deployed configuration of the constriction region 38holds the valve structure 24 in a supra-annular position, above thebasal plane and/or above the diseased native leaflets, away from theheart walls and coronary ostia. Further, the implanted prosthesis trapsnative leaflets 306 against the valve annulus 304, thereby retaining thenative valve 300 in an open state.

With cross-reference between FIGS. 10 and 12B, at 208, the balloon 50(or the balloon 100 (FIG. 6)) is percutaneously delivered to theimplantation site 300. In this regard, delivery of the balloon 50 caninclude removing the delivery device 42 (FIG. 11A) from the patient, andthen manipulating the post-dilatation assembly 44 through the samevasculature path to generally locate the balloon 50 at the implantationsite 300. In other embodiments, the delivery device 42 can beconstructed such that the balloon 50 is delivered through an interiorlumen of the delivery device 42, and located distally beyond the tip 150(FIG. 8). Regardless, at 210, the balloon 50 is axially disposed withinthe implanted prosthetic heart valve 20 as shown in FIG. 12B. In thisregard, the balloon 50 is arranged such that the compliant segment 60 isaxially aligned with a region 310 of the prosthetic heart valve 20 forwhich remodeling is desired. The selected remodeling region 310 can bethe constriction region 38 of the prosthetic heart valve 20, between theleaflets 26 and the outflow end 32. Alternatively, any other region ofinterest to the clinician can be selected. With methodologies in whichthe constriction region 38 serves as the remodeling region 310, themarker (s) 88 provided with or adjacent the balloon 50 can be alignedwith a corresponding end of the stent frame 22 via imaging technology soas to more accurately locate the compliant segment 60 relative to theremodeling region 310.

With reference to FIGS. 10 and 12C, at 212, the balloon 50 is inflated.The first end segment 62 expands to a predetermined outer shape anddiameter, as does the second end segment 64. In instances where theimplanted prosthetic heart valve 20 has fully expanded, the end segments62, 64 may or may not slightly contact corresponding regions of theimplanted prosthetic heart valve 20. Conversely, where self-expansionwas less than complete, the first end segment 62 and/or the second endsegment 64 may more overtly engage the corresponding region of theimplanted prosthetic heart valve 20 and with inflation, cause morecomplete expansion thereof. Regardless, the correspondence in shape ofthe inflated end segments 62, 64 with that of the outflow and inflowregions 36, 34, respectively, guides the compliant segment 60 intobetter alignment with the constriction region 38 (or other region to beremodeled). In other embodiments, optional engagement features (e.g.,the engagement features 90 in FIG. 5) achieve a more positive interfacebetween the segments 62, 64 and the implanted prosthesis 20, therebyenhancing positioning and anchoring of the compliant segment 60 relativeto the remodeling region 310. With continued inflation, the compliantsegment 60 contacts the remodeling region 310, and forces the stentframe 22 to deform in general correspondence with the shape of theinflated compliant segment 60. At 214, the so-remodeled prosthetic heartvalve 20 can again be evaluated relative to the native anatomy of theimplant site 300. If necessary, the balloon 50 can be subjected to anelevated inflation pressure, causing the compliant segment 60 to furtherradially expand to a second profile. As previously described, however,the first and second end segments 62, 64 experience minimal, if any,radial expansion at the elevated inflation pressure, with the expansiveforces of the balloon 50 thus being focused upon the remodeling region310. Thus, the end segments 62, 64 can be located adjacent areas ofconcern such as the conduction system (e.g., AV node, left bundlebranch, paraspecific fibers of mahaim), anterior mitral leaflet, etc.,but will not contact (or only minimally contact) the areas of concernwith inflation of the balloon 50.

The steps of evaluating the shape of the remodeled prosthetic heartvalve 20 and increasing the inflation pressure (and thus the outerdiameter or exerted radially outward expansive force of the compliantsegment 60) is repeated until the clinician is satisfied with the shapeof the remodeled implanted prosthetic heart valve 20. Once the clinicianis satisfied, the balloon 50 is deflated and removed from the patient at216. The remodeled shape as effectuated by the balloon 50 is retained bythe prosthetic heart valve 20.

The balloon 100 (FIG. 6) can be utilized in a manner highly similar tothat described above with respect to the balloon 50. As previouslymentioned, by forming the balloon 100 to include only the compliantsegment 102 (FIG. 6), the clinician can more easily focus the expansiveforces of the balloon 100 onto the remodeling region 310, and can thusavoid contacting or otherwise exerting an overt force onto theprosthetic leaflets 26 or other areas of concern noted above.

The systems, devices, and methods of the present disclosure provide amarked improvement over previous designs. The post-dilatation balloonand use thereof facilitates remodeling of an implanted transcatheterprosthetic heart valve with a self-expanding stent frame. The systems,devices, and methods of the present disclosure are minimally invasive,yet provide techniques for ensuring the implanted prosthetic heart valvemore closely matches the native anatomy and minimizes the risks forparavalvular leaks. In some embodiments, the post-dilatation balloonprovides custom shape and compliance features that avoid damaging theprosthetic leaflets when effectuating remodeling of the implantedprosthesis.

Although the present disclosure has been described with reference topreferred embodiments, workers skilled in the art will recognize thatchanges can be made in form and detail without departing from the spiritand scope of the present disclosure. For example, the post-dilatationballoon assembly can be used with balloon-expandable type stentedprosthetic heart valve delivery devices. With these alternativeembodiments, a first, deployment balloon is employed to generally deploythe prosthesis from the delivery device, and a second, remodelingballoon in accordance with the present disclosure is utilized toeffectuate desired remodeling.

What is claimed is:
 1. A method of remodeling a prosthetic heart valveof a patient, the method comprising: percutaneously delivering aremodeling balloon in a deflated state to an implanted, fully expandedprosthetic heart valve, the balloon including a remodeling segment, theremodeling segment having a longitudinal length less than a longitudinallength of the implanted, fully expanded prosthetic heart valve;arranging the remodeling segment within a region of the implanted, fullyexpanded prosthetic heart valve to be remodeled, the region to beremodeled having a longitudinal length less than the longitudinal lengthof the implanted, fully expanded prosthetic heart valve; inflating theremodeling balloon such that the remodeling segment expands and contactsthe implanted, fully expanded prosthetic heart valve in the region to beremodeled; and expanding the region to be remodeled via continuedinflation of the remodeling segment to alter a shape of the implanted,fully expanded prosthetic heart valve to a remodeled state; wherein thestep of expanding includes remodeling the implanted, fully expandedprosthetic heart valve primarily at the region to be remodeled ascompared to other regions of the implanted, fully expanded heart valve.2. The method of claim 1, further comprising: evaluating the implanted,fully expanded prosthetic heart valve prior to the step of deliveringthe remodeling balloon.
 3. The method of claim 1, wherein the implanted,fully expanded prosthetic heart valve includes a plurality of leaflets,and further wherein the step of expanding the region to be remodeledincludes the remodeling segment not contacting the leaflets.
 4. Themethod of claim 1, wherein the implanted, fully expanded prostheticheart valve is a self-expandable prosthetic heart valve.
 5. The methodof claim 1, wherein the remodeling segment is configured such that in anexpanded state, the remodeling segment has an obround shape inlongitudinal cross-section.
 6. The method of claim 1, wherein theremodeling balloon in an inflated state has a tri-lobed shape.
 7. Themethod of claim 6, wherein the remodeling balloon in an inflated statehas a first segment, a second segment, and a third segment, and furtherwherein the first segment and the third segment are on opposite sides ofthe second segment.
 8. The method of claim 7, wherein a predeterminedshape of the first segment upon inflation differs from a predeterminedshape of the second segment upon inflation.
 9. The method of claim 8,wherein a predetermined shape of the third segment upon inflationdiffers from the predetermined shape of the second segment uponinflation.
 10. The method of claim 9, wherein the predetermined shape ofthe first segment upon inflation differs from the predetermined shape ofthe third segment upon inflation.
 11. The method of claim 10, whereinthe prosthetic heart valve includes leaflets that are arranged toestablish an outflow region and an inflow region of the prosthetic heartvalve, wherein the first segment upon inflation is configured to contactthe inflow region and the third segment upon inflation is configured tocontact the outflow region.
 12. The method of claim 11, furthercomprising expanding the first segment to alter a shape of the inflowregion.
 13. The method of claim 11, further comprising expanding thethird segment to alter a shape of the outflow region.
 14. The method ofclaim 11, further comprising expanding the second segment to alter ashape of a region of the prosthetic heart valve between the inflowregion and the outflow region.
 15. The method of claim 1, whereinexpanding the region to be remodeled via continued inflation of theremodeling segment to alter a shape of the implanted prosthetic heartvalve to a remodeled state reduces paravalvular leakage.
 16. The methodof claim 1, further comprising evaluating a shape of the implanted,fully expanded prosthetic heart valve in the remodeled state.
 17. Amethod of remodeling a prosthetic heart valve of a patient, the methodcomprising: evaluating an arrangement of an implanted, fully expandedprosthetic heart valve; percutaneously delivering a remodeling balloonin a deflated state to the implanted, fully expanded prosthetic heartvalve, the balloon including a remodeling segment, the remodelingsegment having a longitudinal length less than a longitudinal length ofthe implanted, fully expanded prosthetic heart valve; arranging theremodeling segment within a region of the implanted, fully expandedprosthetic heart valve to be remodeled, the region to be remodeledhaving a longitudinal length less than the longitudinal length of theimplanted, fully expanded prosthetic heart valve; inflating theremodeling balloon such that the remodeling segment expands and contactsthe implanted, fully expanded prosthetic heart valve in the region to beremodeled; and expanding the region to be remodeled via continuedinflation of the remodeling segment to alter a shape of the implanted,fully expanded prosthetic heart valve to a remodeled state; wherein thestep of expanding includes remodeling the implanted, fully expandedprosthetic heart valve primarily at the region to be remodeled ascompared to other regions of the implanted, fully expanded heart valve.18. The method of claim 17, wherein expanding the region to be remodeledvia continued inflation of the remodeling segment to alter a shape ofthe implanted, fully expanded prosthetic heart valve to a remodeledstate reduces paravalvular leakage.
 19. The method of claim 17, whereinthe implanted, fully expanded prosthetic heart valve is aself-expandable prosthetic heart valve.
 20. A method of remodeling aprosthetic heart valve of a patient, the method comprising: evaluatingan arrangement of an implanted, fully expanded, self-expandableprosthetic heart valve; percutaneously delivering a remodeling balloonin a deflated state to the prosthetic heart valve, the balloon includinga remodeling segment, the remodeling segment having a longitudinallength less than the longitudinal length of the implanted prostheticheart valve; arranging the remodeling segment within a region of theprosthetic heart valve to be remodeled, the region to be remodeledhaving a longitudinal length less than the longitudinal length of theimplanted prosthetic heart valve; inflating the remodeling balloon suchthat the remodeling segment expands and contacts the prosthetic heartvalve in the region to be remodeled; and expanding the region to beremodeled via continued inflation of the remodeling segment to alter ashape of the prosthetic heart valve to a remodeled state to therebyreduce paravalvular leakage; wherein the step of expanding includesremodeling the implanted, fully expand prosthetic heart valve primarilyat the region to be remodeled as compared to other regions of theimplanted, fully expanded heart valve.